FDA Medical Device Recalls (openFDA)
Medtronic Navigation, Inc.: Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.
- Recall number
- Z-1849-2012
- Recalling firm
- Medtronic Navigation, Inc.
- Product
- Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.
- Status
- Terminated
- Initiated
- 2010-10-12
- Posted
- 2012-06-21
- Terminated
- 2012-06-21
- Reason
- Software Version 3.1.1 does not meet navigational accuracy.
- Root cause
- Software design
- Action
- Medtronic Navigation contacted customers by telephone on 10/12/2010 and with "Urgent Field Safety Notice" follow up letters dated 10/14 or 10/15/2010. Sites were visited by Medtronic Service Representative to complete navigational accuracy testing and either replace or correct the unit.
- Quantity
- 3 units
- Distribution
- Nationwide Distribution including the states of CO, IN, and MN.
- Lot, serial or model codes
- Serial Numbers: 125, 156, 234R.
- 510(k) numbers
- ["K092564"]
- PMA numbers
- not on file
- Product code
- IZL
- Firm FEI
- 3004785967
- Firm city
- Littleton
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28